Durability of Combination of Insulin and GLP-1 Receptor Agonist or SGLT-2 Inhibitors Versus Basal Bolus Insulin Regimen in Type 2 Diabetes (BEYOND)

University of Campania "Luigi Vanvitelli"

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Insulin/Canaglifozin; Drug: Insulin/Dapaglifozin; Drug: Basal Bolus; Drug: IDegLira; Drug: Insulin/Empaglifozin; Drug: IGlarLixi

Study type: Interventional

Funder types: Other

Identifiers

NCT04196231

BEYOND Protocol

Details and patient eligibility

About

BEYOND represents an open-label, parallel, three-arm randomized controlled trial, aimed at evaluating the effects of combination therapy of fixed ratio basal insulin/GLP-1 receptor agonist (GLP-1RA) or basal insulin/SGLT-2 inhibitors (SGLT-2i) on the durability of the glycemic control, as compared with the basal bolus insulin regimen, in people with type 2 diabetes failing to achieve glycemic targets with injective therapy. The potential benefits for participants in the study include the possibility of improving the glyco-metabolic control with drugs that have been evaluated as safe and protective for the heart and the kidneys. The primary outcome of the study is the mean HbA1c change between groups at six months. Participants in the study will be followed for subsequent 18 months in order to evaluate the durability of glycemic control and the chenge of other secondary outcomes.

Enrollment: 258 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Poor glycemic control (HbA1c ≥7.5%)
• Stable basal bolus insulin regimen for almost a year, eventually associated with metformin.

Exclusion criteria

• Type 1 diabetes or secondary diabetes;
• Previous treatment for the last three months with GLP-1RA or DPP-4 inhibitors;
• Hypersensitivity towards active substances or other ingredients of the drugs used in the study
• Participation in other trial with experimental drugs within 30 days
• Diseases that represent contraindication to GLP-1RA use (pancreatitis, gallstones)
• Pregnancy or planned pregnancy within the time of the study
• Serum creatinine > 1,3 mg/dL in women and >1,4 mg/dL in men
• eGFR < 30 mL/min
• Previous cancer or antineoplastic therapy for five years before randomization
• Current therapy with glucocorticoid (oral, topic or sistemic administration) or with antypsichotic drugs
• Previous ketoacidosis
• Any clinical, psychologic or psychiatric condition that is incompatible with the study according to the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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258 participants in 3 patient groups

FR insulin/GLP-1RA

Active Comparator group

Description:

Patients in this arm will receive one of these fixed ratio combo of insulin and GLP-1RAs, according to the current clinical practice and the drugs' data sheet: IDegLira or IGlarLixi

Treatment:

Drug: IDegLira

Drug: IGlarLixi

Insulin/SGLT-2i

Active Comparator group

Description:

Patients in this arm will receive the basal insulin used before the randomization and one of these SGLT-2i according to the current clinical practice and the drugs' data sheet: canagliflozin, dapagliflozin or empagliflozin.

Treatment:

Drug: Insulin/Canaglifozin

Drug: Insulin/Empaglifozin

Drug: Insulin/Dapaglifozin

Basal Bolus

Active Comparator group

Description:

Patients in this arm will receive a basal insulin (glargine, glargine-300 or degludec) at bed-time plus 3 injections of a short-acting insulin analogue (aspart, lispro or glulisine) before meals

Treatment:

Drug: Basal Bolus